Breathing mask for feeding a breathing gas to a mask user and discharge device for discharging breathing gas

ABSTRACT

A breathing mask arrangement for delivering breathable gas to a patient includes a frame having an open construction that provides an annular mask retaining portion, a nasal mask having a body portion structured to be removably attachable within the mask retaining portion of the frame and a sealing portion structured to engage a patient&#39;s face generally along nasal bridge, cheek, and lip regions of the patient&#39;s face, a conduit member in fluid communication with the nasal mask to deliver breathable gas into a nasal breathing space of the nasal mask, and a hose connector coupled to the conduit member. The hose connector is structured to be connected to a gas delivery tube.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. application Ser. No.10/221,574, filed Jan. 28, 2003, now U.S. Pat. No. 7,100,610, which isthe National Phase of International Application PCT/EP01/11954, filedOct. 16, 2001, which designated the U.S., and claims the benefit ofGerman Application Nos. DE 200 17 940.3, filed Oct. 19, 2000, and DE 10051 891.5, filed Oct. 19, 2000, each of which is incorporated herein byreference in its entirety.

The present invention refers to a breathing mask for supplying abreathing air to a user of a mask and it refers to a discharge means fordischarging breathing gas.

Breathing masks of this type are used in particular in the medicalsector, e.g. in the sector of sleep medicine for treating breathingdisorders relating to sleep.

Usually, these masks comprise a sealing lip means for sealing a maskrest zone against the atmosphere. In nose masks, the mask rest zoneextends from the upper lip portion into the facial portion adjoining theside of the nose of the user of the mask and from there to the area ofthe bridge of the nose. The sealing lip means is usually made of anelastomer material and pressed against the mask rest zone via a headband arrangement by exerting a predetermined pressure.

In particular in the long-term use of breathing masks of this type, theproblem occurs that the required sealing effect can only be achieved atcomparatively high mask pressure forces. Due to the required high maskpress forces, the comfort of wearing the mask is affected. Moreover,there is a risk of bruises being generated in the area of the mask restzone.

Thus, the object of the invention is to provide a breathing mask forsupplying a breathing gas, which is characterized by a sufficiently hightightness and by a high comfort when wearing the mask.

This object is achieved according to the invention by a breathing maskfor supplying a breathing mask to a user of the mask, comprising asealing lip means for sealing a mask rest zone, a mask base body forforming a mask interior space and a connection means for connecting atleast one breathing gas line, wherein the mask base body and/or theconnection means are provided with at least one de-coupling structureformed of an elastomer material, which allows a relative movementbetween a circumferential foot portion of the sealing lip meansconnected to the mask base body and the breathing gas line at a tiltangle range of less than 5°.

Thus, it is achieved in an advantageous manner to obtain a sufficientsealing effect at a reduced mask holding force in a reliable manner,since even when moving the head of the user of the mask, forces ormomentums cannot be transferred via the breathing gas line onto thesealing lip means. In a further advantageous manner, a relative movementbetween the sealing lip means resting on the face of the user of themask and a breathing gas line preferably fixed on the front end side(e.g. by a hose holding bracket formed on a reinforcement frame) becomespossible.

The de-coupling structure is according to an especially preferredembodiment of the invention formed by a bellows or roller bellowsstructure. This bellows or roller bellows structure is preferably formedby using a core element which is integral with the sealing lip means.

According to an especially preferred embodiment of the invention, thebellows or roller bellows structure is formed at the connection means.This bellows or roller bellows structure can be provided with hingecharacteristics by zones with adapted wall thickness, by means of whichrotational and tilt momentums as well as axial movements of thebreathing gas mask do not lead to the generation of possible forces onthe sealing lip means.

An also especially preferred embodiment of the invention is given inthat the de-coupling structure is formed on the mask base body. Thismakes it possible to avoid the transfer of undesired forces onto thesealing lip means and at the same time to sufficiently de-couplepossible movements of the mask base body relative to the sealing lipmeans.

An embodiment of the invention that is especially advantageous in viewof low operating noises is given in that at least one channel means isprovided in the area of the de-coupling structure. This channel means isresponsible for creating a connection between the interior of the maskand the atmosphere.

The channel means is preferably formed by a passage opening. The passageopening preferably has a cross section which is adapted to predeterminedpressure/volume flow characteristics.

An especially silent discharge is achieved according to the invention inthat the channel means tapers step-wise or continuously in the flowdirection regarding its cross section.

An embodiment of the invention that is also advantageous in view of alow noise emission is given in that a sharp opening edge is formed in anoutlet opening section of the channel means. A section of the smallestcross section is preferably defined in the channel means, wherein thelength of the section of the smallest cross section is smaller than 2mm. It is possible in an advantageous manner that the channel geometryis designed in a manner that the smallest cross section of the channelmeans is formed in a membrane element. Thereby the coupling of possiblebody sound events into the mass structure is further reduced. Thediameter of the membrane element is preferably 30% larger than thediameter of the throttle passage opening formed therein.

The movable coupling of the sealing lip means is preferably implementedin that the de-coupling structure extends in the mask base body in thecircumferential direction of the sealing lip means along a transitionalportion between a foot portion of the sealing lip means and is formed byat least one circumferential fold or a roller bellows structure.

According to a further aspect of the present invention, and preferablyin combination with the above-described measure, a breathing maskadapted to the individual face structure of the user is provided, whichhas a forehead rest means for supporting the mask in the forehead ornose bridge area of the person, and which comprises a reinforcementelement for reinforcing the breathing mask with a first reinforcementsection associated to the portion of the sealing lip means and a secondreinforcement section associated to the forehead rest portion, whereinthe relative position of the two reinforcement sections to one anotheris adjustably variable.

Thus, it becomes possible in an advantageous manner to obtain an optimalsurface pressure distribution for the respective face structure of theuser of the mask in the area of the sealing lip zone and in the area ofthe forehead area.

An advantageous embodiment of the invention with respect to a simplehandling is given in that both reinforcement sections are coupled to oneanother via a hinge means. The hinge means may in an advantageous mannerbe formed by a film hinge means. According to an especially preferredembodiment of the invention, a fixing means is provided for fixing thetwo reinforcement section in a required relative position. The fixingmeans comprises in an advantageous manner a fixing mechanism, inparticular a catch mechanism. Preferably, a plurality of predeterminedcatch positions can be selected. As an alternative, or in combinationwith this measure, it is also possible to form the fixing means by usingmeans for fixing by adhesion, welding or chemical reaction.

An especially advantageous embodiment of the invention in view ofmanufacturing points of view is given in that the two reinforcementsections are formed integrally. Thus, it is possible to form the tworeinforcement section e.g. of a thermoplastic plastic material by usingan only two-piece shaping tool. The two reinforcement sections may beinjection-molded in a direction advantageous in view of removal from themold.

The reinforcement element is preferably shaped frame or skeleton-like orat least in the area of the sealing lip element in a bell-shaped manner.In the case of a skeleton or frame-like design, the individual websections preferably have a substantially profile cross section. A highrigidity is achieved by a low dead weight of the reinforcement element.

The first reinforcement or frame section preferably has a contoursubstantially corresponding to the mask rest zone. The secondreinforcement or frame section preferably extends up to a portionlocated in the application position of the mask above the eyebrow of theuser of the mask.

An embodiment of the invention that is especially advantageous whenusing an elastomer mask base body is provided in that the reinforcementelement is provided with coupling sections for coupling a head bandmeans. This makes it possible to introduce the mask half forces withoutan inadmissible deformation of the mask.

The reinforcement element is preferably formed of a plastic material. Asan alternative, or in combination therewith, it is possible to make thereinforcement element of a metal material in particular of a bendablewire or profile material. It is also possible to form the reinforcementelement of an alt least locally thermo-deformable material, inparticular a thermoplastic material having a rigid inset.

It is in particular possible to provide a wire inset in the area of thebending-neutral zone of the profile material.

The profile material preferably comprises at least one rigid lead, e.g.made of a wire material. It is possible to enable at least locally adeformation of the profile material, e.g. by heating up the material sothat a further adaptability of the reinforcement or frame element to theface structure is possible.

An especially advantageous adaptability of the breathing mask to theface structure of the user of the mask is achieved according to anespecially advantageous embodiment of the invention in that thebreathing mask comprises a mask base body made of an elastomer material.Thus, it becomes possible to affect the course of the sealing lip zoneand the surface pressing distribution in this zone by an arbitrarydeformation of the first reinforcement section.

In an advantageous manner the forehead rest means comprises a restelement which is formed of an elastomer material.

An especially advantageous embodiment according to the invention interms of hygiene is given in that the sealing lip means is formedintegrally with the mask base body. This integral design can be achievedby the common formation in a shaping tool or by adhering the sealing lipmeans to the mask base body preferably by including a reinforcementmeans. It is also possible to form the mask base body and the sealinglip means and preferably also the padding members of the forehead restmeans in the course of a vulcanization process.

According to a special aspect of the present invention, the paddingmembers of the forehead means are preferably formed integrally with thesealing lip means and/or the mask base body. In the case of amulti-piece design of the mask it is possible to couple the sealing lipmeans to the mask body via the reinforcement element. The connectionportion between the mask base body and the forehead rest means may beeffective as an elastomer hinge structure.

The reinforcement element is, according to an especially preferredembodiment of the invention releasably coupled with the sealing lipmeans and/or the mask base body. Thus it becomes possible in anadvantageous manner to use the reinforcement element a plurality oftimes. The reinforcement element is preferably coupled via a catch orengagement profile structure with the mask base body.

The reinforcement element preferably consists of a plurality of pieces.In an advantageous manner, the mask base body is made of a transparentor translucent elastomer material. An especially favorable embodiment ofthe invention in view of a high comfort of wearing the mask is given inthat the sealing lip means has a satin-like mat surface. By therealization of so-called lotus flower structures, a cleaning structureimproved in terms of hygiene is achieved.

The hinge fixation can preferably also be implemented reversibly, e.g.by not glue or by chemically releasable adhesives. It is also possibleto provide thermo-deformable structure especially in the area of thehinge portion, said structures being repeatedly plastically deformableand allowing another adjustment of the relative position of the tworeinforcement or frame section e.g. by the supply of heat.

It is also possible to form a plurality of hinge or adjustment zones inthe reinforcement element or in the frame structure thereof so that forinstance also adjustment possibilities for adaptation to the individualcurvature of the forehead, the width of the nose bridge and the upperlip structure are possible.

In particular when forming the reinforcement element as a locallydeformable structure, a sufficient strength can be achieved at a smallspace in that the reinforcement element is formed of a compoundmaterial. A wire/thermoplastic compound material is particularlysuitable as a compound material.

The adjustability of the at least two reinforcement or frame sectionwith respect to each other can also be obtained according to theinvention in that the two reinforcement or frame sections can be joinedin different coupling positions, e.g. by corresponding permutatablyconnectable joining portions or selectable joining elements.

Further details can be derived from the following description inconnection with the drawing.

FIG. 1 shows a perspective view of a preferred embodiment of a breathingmask comprising an elastomer mask base body and an integral foreheadrest means, wherein a reinforcement element is provided through whichthe position of the forehead rest means is adjustably variable relativeto a sealing lip means that is formed integral with the forehead restmeans;

FIG. 2 shows a perspective view of a frame-like reinforcement element,as it is provided in the embodiment according to FIG. 1;

FIG. 3 shows a further perspective view of said reinforcement element,here with a view onto a fixing member that can be locked in a pluralityof fixing positions;

FIG. 4 shows a simplified perspective view of a further embodiment of abreathing mask with an elastomer de-coupling structure formed in thearea of the breathing gas conducting means;

FIG. 5 shows a perspective view of a third embodiment of a breathingmask comprising a mask base body formed of an elastomer material, and ade-coupling structure formed at the mask base body, said de-couplingstructure being formed by bellows.

FIG. 6 shows a perspective view of a fourth embodiment of a breathingmask, also comprising a mask base body formed of an elastomer material,however, having a de-coupling structure formed according to the rollerbellows principle;

FIG. 7 shows a side view of a fifth embodiment of a breathing mask, alsocomprising a mask base body formed of an elastomer material, and aconnection means for the breathing gas line connected thereto, wherein ade-coupling structure is formed between the connection means and themask base body and in the area of the sealing lip means;

FIG. 8 shows a preferred embodiment of a connection section for abreathing gas line with integrated gas discharge openings;

FIG. 9 shows a perspective view of a further embodiment of a connectionmeans for a breathing gas line with a plurality of circumferentialbellows and integrally formed discharge openings;

FIG. 10 shows a simplified sectional view for explaining a furtherembodiment of a channel means for discharging breathing gas;

FIGS. 11 a and 11 b show sketches for explaining the structure of adeformable structure suitable as a power and/or pressure display means;

FIG. 12 shows a detailed sketch for explaining a preferred embodiment ofreinforcement webs for preventing a locking of the passage openings.

The view according to FIG. 1 shows a breathing mask, as it may inparticular be used for carrying out a CPAP therapy. The breathing maskcomprises a mask base body 1, which in the embodiment shown is formed ofa fully transparent elastomer silicone material. The mask base body 1defines an interior of the mask sufficiently dimensioned for theaccommodation of the nose of the user of the mask. The sealing of theinterior of the mask space with respect to the facial surface of theuser of the mask is carried out via a sealing lip means 2, which in thisview is almost fully covered. The sealing lip means 2 comprises asealing lip formed of an elastomer material, which rests on the half ofthe face of the mask user under elastic deformation and which defines anose accommodation opening through which at least the nose tip area ofthe user of the mask may reach the mask interior defined by the maskbase body 1.

The breathing mask is provided with a forehead rest means 3, which inthis case comprises a forehead padding means 4. The forehead paddingmeans 4 is in the embodiment shown also made of an elastomer materialand is also formed integrally with the sealing lip means 2 andintegrally with the mask base body 1. This integral design of mask basebody 1, sealing lip 2 and forehead padding means 4 is achieved byforming a connection web section 5, which couples the forehead paddingmeans 4 with the mask base body 1 in a manner that the position can bechanged. In the circumferential portion of the mask body 1, areinforcement element 6 is provided, which in this case is formed as aframe-like structure. The reinforcement element 6 comprises a firstreinforcement section 6 a following the circumferential contour of thesealing lip means 2 and a second reinforcement section 6 b extendinginto the forehead rest means 3. The two reinforcement sections 6 a, 6 bare coupled in a manner movable with respect to each other. The couplingof the two reinforcement sections 6 a, 6 b, is implemented in theembodiment shown by a hinge means 7, which in this case is formed by afilm hinge section 8. The relative position of the forehead paddingmeans 4 relative to the mask base body 1 or to the sealing lip means 2produced by pivoting the two reinforcement sections 6 a, 6 b withrespect to each other, may permanently be defined via the fixing means9.

The fixing means 9 in this case comprises a fixing element 10, which canbe engaged with a holding element 11 in different fixing positions.

In the embodiment shown, the holding element 11 is substantially rigidlyconnected to the first connection section 6 a. The fixing element 10 ispivotally connected to the second reinforcement section 6 b. Thecoupling of the fixing element 10 and of the holding element 11 inselected coupling positions is carried out in this case via plug bores12, which are formed in the fixing element 10. These plug bores 12 canbe engaged with a fixing pin that cannot be seen in this case. Thefixing pin is formed at a front end face of the holding element 11facing the fixing element 10. As an alternative to the mechanism shownhere, it is also possible to use other mechanisms for defining therelative position of the first reinforcement section 6 a with respect tothe second reinforcement section 6 b.

The reinforcement means 6 is coupled to the mask base body 1 in a mannerthat the mask base body 1 and also the sealing lip means 2 have a shapealso determined by the reinforcement element 6. In the embodiment shown,the coupling of the reinforcement element 6 with the mask base body 1 isperformed by a circumferential groove 14 into which the frame-likereinforcement element 6 is inserted. For an improved coupling of thereinforcement element 6 with the mask base body 1 or with the sealinglip means 2, the circumferential groove is profiled in the area of theinner surfaces of the grooves complementary to the reinforcement element6.

The reinforcement element 6 is provided with a coupling means 15 throughwhich a band element below a head band arrangement can be coupled to thebreathing mask. In the embodiment shown, the coupling means 15 is formedas a bracket-like flap, which is formed integrally with thereinforcement element. As an alternative, it is also possible to useconstructively differently built coupling elements, e.g. catch or snapmeans for coupling the head band with the reinforcement element 6. Bythe direct introduction of the tensile forces of the head band into thereinforcement element 6 an inadmissible deformation of the mask basebody 1 and of the sealing lip 2 is avoided.

In the area of the forehead rest means 3 a coupling means 16 is alsoprovided, which in the embodiment shown basically corresponds to thecoupling means 15 provided in the area of the mask base body 1.

The reinforcement element 6 or its second reinforcement or frame section6 b formed in the area of the forehead rest means 3 is connected withthe forehead padding means 4. In the embodiment shown, the coupling ofthe forehead padding means 4 with the second reinforcement section 6 bis implemented similar as the coupling of the first reinforcementsection 6 a with the mask base body 1 in that the second reinforcementsection 6 b is inserted into a groove formed in the forehead paddingmeans 4.

The forehead padding means 4 is formed of an elastomer material andcomprises a plurality of pocket sections 17, 18. The padding propertiesof the forehead padding means 4 may be influenced in a defined manner bythe pocket sections 17, 18.

A bellows structure 19 is provided on the mask base body 1 through whicha breathing hose connection adapter 20 is pivotally coupled with themask base body.

The bellows structure 19 in the embodiment shown is also formedintegrally with the mask base body 1, which prevents the possiblegeneration of gaps in a manner that is advantageous in terms of hygiene.A hose pin section 21 is connected to the bellows structure 19, saidhose pin section being dimensioned regarding its inner diameter in amanner that the breathing hose connection adapter 20 can be insertedtherein in a fixedly seated manner. Instead of the breathing hoseconnection adapter 20, it is also possible to provide a CO₂ rinseadapter, as it is described in the applicant's German patentspecification 198 40 760.2.

FIG. 2 shows the reinforcement element 6 in detail provided in thebreathing mask according to FIG. 1. The first reinforcement section 6 aassigned to the mask base body 1 of the breathing mask as well as thesecond reinforcement section 6 b associated to the forehead rest means 3(FIG. 1) are formed in this case by web-like elements, which have asubstantially polygonal, in particular rectangular cross section. Thecoupling means 15, 16 already explained in connection with FIG. 1 areformed integrally with these web-like elements. In this view thecoupling point formed in this case as a film hinge 22 can clearly beseen for coupling the two reinforcement sections 6 a, 6 b. The fixingelement 10 is also supported via a film hinge portion 23 in a mannerthat, as shown by arrow P, it is pivotal in a sufficient angular range.By pivoting the fixing element 10 it is achieved that this fixingelement releases a fixing pin 24, which is formed in the end portion ofthe holding element 11. As long as the fixing element 10 is not coupledto the holding element 11, it is possible to pivot the secondreinforcement section 6 b relative to the first reinforcement section 6a into a desired position. By engaging the engagement structure providedat the fixing element 10 with a corresponding complementary engagementstructure of the holding element 11, it becomes possible to fix the tworeinforcement sections 6 a, 6 b in the desired relative position withrespect to each other. The fixing element 10, the holding element andthe section of the second reinforcement element 6 b extending betweenthe film hinge 22 towards the film hinge 23 form, in the embodimentshown, a triangular structure, through which the relative position ofthe second reinforcement section 6 b relative to the first reinforcementsection 6 a can be defined in an adjustable manner. As an alternative tothis coupling structure that can be manufactured in a particularadvantageous manner, it is also possible to use deviating couplingstructures for coupling the two reinforcement sections 6 a, 6 b.

The first reinforcement section 6 a comprises in the embodiment shown asubstantially saddle-like outer contour. In a direction perpendicularwith respect to the mask rest surface, the first reinforcement section 6a is drawn upwards in the nose bridge portion in a manner that this nosebridge portion does not fall below a predetermined minimum distance tothe face half of the user of the mask.

FIG. 3 shows the mask frame according to FIG. 2 in another perspective.The fixing element 10 in this case comprises four catch bores 26, 27, 28and 29.

The fixing element 10 is coupled with the holding element 11 in a mannerthat the catch bore 29 can be engaged with the fixing pin 24 of theholding element 11. When coupling the fixing element 10 with the holdingelement 11 by using the catch bore 29, the second reinforcement section6 b is pivoted towards the forehead portion of the user of the mask in amanner that the portion of the first reinforcement section 6 atraversing the nose bridge is lifted up to the greatest extent. Byselecting the catch bore 28 a configuration is chosen, in which theportion of the first reinforcement section 6 a traversing the nosebridge is already approximated to the nose bridge of the patient. Evenflatter configurations are obtained by the catch bores 27 and 26.

It is possible to introduce an adhesive in the area of the couplingelement formed as a film hinge 22 in this case between the tworeinforcement sections, which causes the relative position of the tworeinforcement sections 6 a, 6 b to be durably fixed with respect to eachother. The fixing element 10 and possibly also the holding element 11may be removed after curing of the adhesive material. The adjustment ofthe breathing mask is performed in an advantageous manner by using thefully assembled breathing mask. It is also possible to adapt thereinforcement element in the disassembled state to the face structure ofthe user of the mask and to subsequently couple it to the mask basebody. In an advantageous manner, further adjustment alternatives areprovided, though which for instance the position of the forehead paddingmeans can be adjusted in vertical and/or horizontal direction. As analternative to the formation of the coupling portion between the tworeinforcement sections as a hinge point, it is also possible to providecoupling alternatives through which for instance an adjustmentalternative of the two reinforcement elements 6 a, 6 b e.g. by thesupply of heat, is given.

The breathing mask shown in FIG. 4 comprises a connection means 32integrally formed with the mask base body 31 for a breathing gas line(not shown). In a transitional area between the connection means 32 andthe mask base body 31, a de-coupling structure 33 is provided, which isformed in the embodiment shown by a bellows means. The bellows meanscomprises a first fold collar 34 and a second fold collar 35. Inparticular the first fold collar 34 comprises two circumferential walls36, 27 extending in the radial direction. These two circumferentialwalls 36, 37 are formed as surfaces forming the envelope of a cone, andhave a wall thickness distribution selected in view of a predeterminedsystem rigidity. The de-coupling structure is formedrotational-symmetrical. An especially large breathing gas passage crosssection at a comparatively small disturbance of the field of vision isachieved in an advantageous manner in that the breathing gas linesection in the area of the nose bridge has an elliptical or polygonalcross section. The de-coupling structure is in this case formed in arotational-symmetrical manner. As an alternative it is also possible toform the flanks of the fold collars in a manner that they have differentdepths and possible changing wall thickness in the circumferentialdirection.

In the embodiment shown, at least one breathing gas passage opening 38is formed in the circumferential wall 36 facing the forehead portion ofthe mask user in the application position of the breathing mask. Throughthis breathing gas passage opening, a discharge of at least partiallyused breathing gas to the atmosphere can take place. In the area of thesecond fold collar 35 a plurality of breathing gas passage openings 39are formed through which a breathing gas discharge can also take placeacross the forehead portion of the user of the mask. The breathing gaspassage openings 38 and 39 are aligned in a manner that breathing gasexiting therefrom does not directly collide with the wall sections ofthe de-coupling structure or the connection means. The breathing gaspassage openings 38 are preferably arranged in a manner that the airexiting cannot hit the forehead portion of the user of the mask.

It is also possible to form the de-coupling structure in a manner thatan abutment characteristics is achieved so that a de-coupling is onlypermitted within a predetermined area of movement.

In the breathing mask shown in this case, a forehead rest means 40integrally formed with the mask base body 31 is shown. The sealing lipmeans 2 for sealing the face rest zone is also formed integrally withthe mask base body 31 or it is formed integrally with the forehead restmeans 40 in the embodiment shown. The position of the forehead restmeans 40 with respect to the mask base body 31 or with respect to thesealing lip means 2 is variable by means of an adjustment means.

In the embodiment of a breathing mask shown in FIG. 5, the mask basebody 31 is also formed of an elastomer material, but contrary to theabove-described embodiment it is provided with a plurality of folds,through which a substantially mechanical de-coupling of the connectionmeans 32 from the sealing lip is achieved. In this embodiment, thebreathing mask also comprises a forehead rest means 40, which similar tothe above-described embodiment may be formed integrally with the maskbase body 31.

The folds 41, 42, 43 are aligned in a manner that they bridge over thenose bridge portion in an arc-like manner in application position of thebreathing mask. As an alternative to the embodiment shown with threecomparatively deep folds, it is also possible to provide the mask basebody 31 with a larger amount of corresponding folds, wherein the elasticproperties of the individual folds are preferably adapted in a mannerthat predetermined properties with respect to the coupling of theconnection means 32 and the sealing lip means 2 result.

The breathing mask shown in FIG. 6 comprises, similar to theabove-described breathing mask, a de-coupling structure formed in thearea of the mask base body 31. In the embodiment shown, the de-couplingstructure is formed by a plurality of roller bellows zones 44, 45, 46.In addition to these roller bellows zones 44, 45, 46, a furtherde-coupling structure 33 is provided in the area of the connection means32, which similar to the embodiment described in FIG. 4, comprises twofold collars 34, 35.

The support of this breathing mask in the forehead portion of a user ofa mask is in this case also implemented by a forehead rest means 40which in this case is formed integrally with the mask base body 31.

The connection means 32 in this case is formed integrally with the maskbase body 31 and is also made of an elastomer material. The connectionmeans 32 comprises a circumferential bead 47 through which an improvedcoupling with a breathing as line is achieved.

The breathing mask shown in FIG. 7 comprises a mask base body 31 made ofan elastomer material having a connection means 32 that is also made ofan elastomer material. The connection means 32 is formed integrally withthe mask base body, wherein a de-coupling structure 33, in this caseformed by one single bellows, is formed in a transitional portion of theconnection means 32 in the mask base body 31. A plurality of breathinggas passage openings 39 are formed in the area of the de-couplingstructure for discharging breathing gas from the interior of the maskdefined by the mask base body 31. The breathing gas passages 39 havechannel cross sections formed with respect to a predetermined dischargeflow behavior. The breathing gas passages 39 may, as shown as anexample, not only have round cross sections, as explained above, butthey also may have polygonal, cross-shaped or other arbitrarily chosengeometries. The breathing gas passage openings are, however, preferablyformed in a manner that the air flow therethrough is not directedtowards the forehead portion of a user of a mask, but that it isdirected in the hose direction in particular along the side of the hosewall opposite to the user of the mask.

FIG. 8 shows a discharge means 50 for discharging breathing gas. Thedischarge means 50 in this case forms a connection means 32 forconnecting a breathing gas line and a de-coupling structure 33, which inthis case comprises a plurality of fold collars 34, 35. On a sideopposite to the connection means 32, the discharge means 50 is providedwith an attachment structure 51 through which the discharge means 50 canbe coupled in a sealing manner to a mask base body of a breathing maskor with a further breathing gas coupling section. Breathing gas passages39 through which a discharge of breathing gas from the interior definedby the discharge means 50 to the atmosphere can take place are formed inan area of a circumferential section of the first fold collar 34extending at an angle of approx. 120°.

FIG. 9 shows a further embodiment of a discharge means 50 fordischarging at least partially used breathing gas. The discharge means50 comprises a connection means 32 provided for connecting a breathinggas line, and a connection structure 52 formed on the side opposite tothe connection means 32, through which said connection structure thedischarge means can be coupled to the mask base body 31 or to a furtherbreathing gas line section. A de-coupling structure 33 is providedbetween the connection structure 52 and the connection means 32, throughwhich a relative movement between the connection means 32 and theconnection structure 52 in a predetermined area of movement is admitted.In the embodiment shown, axial movements in an area of movement of up to10 mm and tilt movements in an angular range of approx. 30° are allowed.In a circumferential section of a circumferential wall 36 of the firstfold collar 34, breathing gas passage openings 39 are formed similar tothe above-described embodiment. The breathing gas passage openings 39are formed as narrow, substantially radially aligned slots. The wallthickness of the circumferential walls of the two fold collars 34 arechosen thinner in the area of the fold portions than in the wall portionextending between the fold portions. The embodiment of a discharge meansshown comprises in the area of the connection means 32 an inner diameterof 18 mm and in the area of the de-coupling structure 33 an outerdiameter of 35 mm. The axial length of the discharge means 50 is 54 mmin unloaded condition. The discharge means 50 is formed of an elastomermaterial—in this case a fully transparent silicone rubber. The maximumwall thickness of the discharge means 50 is 4 mm.

FIG. 10 shows the sketch of a preferred embodiment of a channel meansfor discharging breathing gas. The breathing gas path defined in thiscase extends through a passage opening 53 in a first intermediatechamber 54, which communicates with the atmosphere via a gap portion 55.A plurality of web portions 56 are formed in this gap portion, throughwhich said web portions the throttle characteristics of the gap portionare influenced. The flow behavior of the breathing gas path can beinfluenced in a defined manner by the length of the gap portion 55 inparticular in connection with the webs 56. Such a breathing gas path fordischarging breathing gas from a mask interior to the atmosphere candirectly be formed in the area of a connection means for connecting abreathing gas line. The structure shown in this case is preferablyformed integrally of a fully elastomer material. For cleaning purposesit is possible to turn up an upper lid wall 57 towards the top. Arequired minimum gap measure in the gap portion 55 can be achieved byweb sections that are not shown, which extend section-wise up to theinner surface of the lid wall 57.

FIG. 11 shows an elastomer structure, which in connection with abreathing mask is directly suitable for display of the deformationtaking place when applying the breathing mask. It is for instancepossible to provide a color mark in the area of the inner wall of a foldor bellows structure 60, said color mark becoming visible depending onthe deformation of the fold or bellows structure. If for instance thefold or bellows structure 60, as shown in FIG. 11, is upset at amaximum, the color mark arranged in the area of the inner wall of thefold or bellows structure can no longer be seen from the outside. Thisresults for instance in an inadmissibly high surface pressure in thearea of the forehead rest and/or in the area of the sealing lip means ofa correspondingly designed breathing mask. It is also possible to checkby means of such a fold or bellows structure 60, whether a sufficientmask holding force is exerted onto the breathing mask. In such anembodiment, the colored mark can for instance be arranged in a mannerthat it is visible in the case of insufficient mask holding forces andis covered when the mask holding forces are sufficient.

FIG. 12 shows a section of a discharge means, for discharging breathinggas, which is formed of an elastomer material. The discharge meanscomprises a circumferential wall 70, formed in this case as a foldcollar 73. The circumferential wall is provided with a plurality ofpassage openings 38 for discharging breathing gas. Webs 71 are formed inthe interior of the fold collar 73, said webs being formed integrallywith the circumferential wall 70. The webs 71 act as a fold safety meansand ensure that the passage openings 38 are open permanently. A divisionof the gas flow is further achieved by the webs 71, which leads to alow-noise discharge of the breathing gas to the atmosphere (U). Thepassage openings in this case have a circular cross section. A furtherfold collar 74 is connected to the fold collar 73 that is provided withthe passage openings 38. This fold collar 74 is comparatively rigidlycoupled with the first fold collar 73 and also has a small height sothat a covering of the passage opening 38 by a further fold collar 74 isnot possible. A hinge fold collar 75 is connected to the further foldcollar 74. This hinge fold collar defines a circumferential hinge zone76 in the area of its maximum diameter and an inner hinge zone 77 in theinner portion. In the area of the inner hinge zone 77 and thecircumferential hinge zone 76, the wall thickness of the circumferentialwall 70 is formed so small that a comparatively easy movability of thetwo sections of the discharge means opposing each other is given. Thecircumferential walls 78 of the fold collar 74 and the circumferentialwall 79 of the hinge fold collar 75 together restrict the maximum pivotangle of the two fold collars with respect to each other.

The function of the above-described breathing mask is not described indetail by means of the following example.

To carry out a CPAP therapy, the breathing mask is removed from asterile packaging, and the fixing element 10 is pivoted into a releaseposition so that the reinforcement section 6 b can be pivoted withrespect to the first reinforcement section 6 a around the film hingepoint. A breathing gas hose is connected to the breathing mask via arotary or quick-snap adapter, in that, this breathing gas hose isconnected to the quick-snap adapter and this quick-snap adapter isinserted into the breathing hose connection adapter 20. Breathing gas ata predetermined excess pressure of e.g. 8 mbar is supplied via thebreathing gas hose. Now the breathing mask is applied onto the noseportion of the user of the mask. For this purpose, a lower head bandarrangement is passed through. The tensile stress in the lower head bandarrangement is adjusted in a manner that a sufficient tightness of thesealing lip means 2 is ensured. Now the breathing mask is tilted in theapplication position away from the nose back or towards the nose backuntil an optimal abutment of the sealing lip means 2 in the area of thenose back is achieved. Now the upper forehead padding means 4 isslightly pressed against the forehead of the user of the mask. Therelative position of the first reinforcement section 6 a achievedthereby is fixed relative to the second reinforcement section 6 b, inthat the fixing element 10 is engaged with the holding element 11.

As a result of the excess pressure prevailing in the breathing gas line,CO₂ flows through the passage openings formed in the fold collar Thepassage openings are dimensioned and formed in a manner that apredetermined pressure/volume characteristic is achieved so that asufficient discharge of the breathing air exhaled into the breathingmask or into the breathing bas line to the atmosphere is achieved.

It is ensured by the webs formed in the fold bellows that the openingsare not closed due to a compensation movement allowed by the de-couplingstructure.

The breathing mask is now adjusted ready for use. By coupling thecoupling means 16 in the area of the forehead rest means 3, thebreathing mask is also fixed in the forehead portion of the user of themask by the upper head band arrangement on the user of the mask.

It is possible to fix the relative positioning achieved in this case byadditional measure e.g. an element blocking in a locking manner (e.g.safety element). If these additional fixing means are able to take aload it is possible to remove the fixing element 10 and possibly alsothe holding element 11.

It is also possible to chose a reinforcement element from areinforcement element set by means of the ideal configuration of thebreathing mask detected via the fixing means 9, which provides thedesired relative position by renouncing the fixing means 9 of thesealing lip means and the forehead padding means 4, and to exchange sucha reinforcement element by the above-mentioned reinforcement element.

1. A breathing mask arrangement for delivering breathable gas to apatient, comprising: a frame having an open construction that provides amask retaining portion; a mask having a body portion structured to beremovably attachable within the mask retaining portion of the frame anda sealing portion structured to engage a patient's face generally alongnasal bridge and check regions of the patient's face, the body portiondefining a front side of the mask and the sealing portion defining arear side of the mask; a conduit member in fluid communication with themask to deliver breathable gas into a breathing space of the mask; and ahose connector coupled to the conduit member, the hose connectorstructured to be connected to a gas delivery tube, wherein the bodyportion defines the breathing space of the mask, and when attached tothe frame, the body portion forms an exterior surface exposed at thefront side of the mask.
 2. The breathing mask arrangement according toclaim 1, wherein the body portion of the mask includes a groove toreceive the open frame.
 3. The breathing mask arrangement according toclaim 1, wherein the body portion of the mask includes a first sideincluding said sealing portion and a second side defining the breathingspace, the first and second sides being provided on opposite sides ofthe open frame.
 4. A breathing mask arrangement for deliveringbreathable gas to a patient, comprising: a frame having a mask retainingportion; a mask having a body portion and a sealing portion integrallyformed in one piece from an elastometric material, the body portiondefining a mask interior breathing chamber structured to accommodate thepatient's nose and being removably attachable to the mask retainingportion of the frame, and the sealing portion structured to engage apatient's face generally along nasal bridge and check regions of thepatient's face; a conduit member in fluid communication with the mask todeliver breathable gas into a breathing space of the mask; and a hoseconnector coupled to the conduit member, the hose connector structuredto be connected to a gas delivery tube the frame being relatively rigidcompared to the elastomeric material of the mask.
 5. The breathing maskarrangement according to claim 4, further comprising a forehead supportsupporting elastomeric forehead padding that is structured to engage apatient's forehead, the forehead support being moveably coupled to theframe to allow movement of the forehead support relative to the framealong an arcuate path to thereby adjust the position of the foreheadpadding relative to the patient.
 6. The breathing mask arrangementaccording to claim 5, wherein the forehead padding of the foreheadsupport is integrally formed in one piece along with the body portionand sealing portion of the mask.
 7. The breathing mask arrangementaccording to claim 1, wherein the mask retaining portion includes aninwardly facing retaining surface that engages an outwardly facingsurface of the body portion.
 8. The breathing mask arrangement accordingto claim 1, wherein the mask retaining portion includes a ring-shapedconfiguration.
 9. The breathing mask arrangement according to claim 1,wherein the mask retaining portion encloses or wraps around the bodyportion.
 10. The breathing mask arrangement according to claim 1,wherein each end of the mask retaining portion is substantially openended.
 11. The breathing mask arrangement according to claim 1, whereinthe mask retaining portion includes a rectangular cross-section.
 12. Thebreathing mask arrangement according to claim 1, wherein the bodyportion defines a mask interior breathing chamber.
 13. A breathing maskarrangement for delivering breathable gas to a patient, comprising: aframe having an open construction that provides a mask retainingportion; and a mask having a body portion defining a mask interiorbreathing chamber and structured to be removably attachable within themask retaining portion of the frame and a sealing portion structured toengage a patient's face at least along nasal bridge and cheek regions ofthe patient's face, the body portion and sealing portion integrallyformed in one piece from an elastomeric material.
 14. The breathing maskarrangement according to claim 13, wherein the body portion and thesealing portion are integrally formed in one piece, and the body portiondefines a mask interior breathing chamber structured to accommodate atleast the patient's nose.
 15. The breathing mask arrangement accordingto claim 13, wherein the mask retaining portion includes an inwardlyfacing retaining surface that engages an outwardly facing surface of thebody portion.
 16. The breathing mask arrangement according to claim 13,wherein the mask retaining portion includes a ring-shaped configuration.17. The breathing mask arrangement according to claim 13, wherein themask retaining portion encloses or wraps around the body portion. 18.The breathing mask arrangement according to claim 13, wherein each endof the mask retaining portion is substantially open ended.
 19. Thebreathing mask arrangement according to claim 13, wherein the maskretaining portion includes a rectangular cross-section.
 20. A breathingmask arrangement for delivering breathable gas to a patient, comprising:a frame having an open construction that provides a mask retainingportion, the frame having a front side and a rear side; a mask having abody portion structured to be removably attachable within the maskretaining portion of the frame and a sealing portion structured toengage a patient's face, the sealing portion being oriented towards therear side of the frame, the body portion of the mask including acircumferential groove to receive the mask retaining portion of theframe such that a selected portion of the body portion including thecircumferential groove is at least partly surrounded by the retainingportion and the retaining portion defines an opening through which theselected portion is exposed towards the front side of the frame.
 21. Thebreathing mask arrangement according to claim 20, wherein the maskretaining portion includes an inwardly facing retaining surface thatengages an outwardly facing surface of the groove.
 22. A breathing maskarrangement for delivering breathable gas to a patient, comprising: aframe having an open construction that provides a mask retainingportion; and a mask having a body portion that defines a mask interiorbreathing chamber and a sealing portion structured to engage a patient'sface, wherein the mask is removably attachable within the mask retainingportion of the frame such that the breathing chamber is provided on oneside of the mask retaining portion and the sealing portion is providedon the opposite side of the mask retaining portion.
 23. The breathingmask arrangement according to claim 22, wherein the body portion and thesealing portion are integrally formed in one piece.
 24. The breathingmask arrangement according to claim 22, wherein the mask retainingportion encloses or wraps around the body portion.
 25. The breathingmask arrangement according to claim 22, wherein the mask retainingportion is structured to support the sealing portion jointly with thebody portion.
 26. A breathing mask arrangement for delivering breathablegas to a patient, comprising: a frame having an open construction thatprovides a mask retaining portion; and a mask having a body portion thatdefines a mask interior breathing chamber and a sealing portionstructured to engage a patient's face, the body portion and sealingportion being integrally formed in one piece from an elastomericmaterial, wherein the mask is removably attachable within the maskretaining portion of the frame, the mask retaining portion including agenerally ring-shaped configuration that defines an inwardly facingretaining surface adapted to engage an outwardly facing side wall of thebody portion.
 27. The breathing mask arrangement according to claim 26,wherein the body portion and the sealing portion are integrally formedin one piece.
 28. The breathing mask arrangement according to claim 26,wherein the mask retaining portion encloses or wraps around the bodyportion.
 29. The breathing mask arrangement according to claim 26,wherein the mask retaining portion is structured to support the sealingportion jointly with the body portion.
 30. The breathing maskarrangement according to claim 26, wherein the inwardly facing retainingsurface faces inwardly towards the mask interior breathing chamber andthe outwardly facing side wall faces outwardly away from the maskinterior breathing chamber.
 31. A breathing mask arrangement fordelivering breathable gas to a patient, comprising: a frame defining anaperture and a mask retaining portion within the aperture; a mask havinga body portion and a sealing portion integrally formed in one piece, thebody portion defining a mask interior breathing chamber and having aportion that is inserted within the aperture and fully surrounded by theframe, the body portion being removably attachable to the mask retainingportion of the frame, and the sealing portion structured to engage apatient's face; the frame including a pair of upper coupling structuresstructured to be removably connectable to an upper band arrangement of aheadband assembly and a pair of lower coupling structures structured tobe removably connectable to a lower band arrangement of the headbandassembly for maintaining the mask arrangement in a desired position on apatient's face; the body portion including a groove into which the maskretaining portion of the frame is inserted; and a tubular connectorthrough which a hose connection adaptor is coupled with the mask. 32.The breathing mask arrangement according to claim 31, wherein the maskretaining portion defines an inwardly facing retaining surface adaptedto engage an outwardly facing side wall of the body portion.
 33. Thebreathing mask arrangement according to claim 32, wherein the inwardlyfacing retaining surface faces inwardly towards the mask interiorbreathing chamber and the outwardly facing side wall faces outwardlyaway from the mask interior breathing chamber.
 34. A breathing maskarrangement for delivering breathable gas to a patient, comprising: aframe having a mask retaining portion; a mask having a body portionstructured to be removably attachable to the mask retaining portion ofthe frame and a sealing portion structured to seal around the patient'snose; a forehead support supporting forehead padding that is structuredto engage a patient's forehead; a conduit member in fluid communicationwith the mask to deliver breathable gas into a breathing space of themask; and a hose connector coupled to the conduit member, the hoseconnector structured to be connected to a gas delivery tube; theforehead support including a pair of upper coupling structuresstructured to be removably connectable to an upper band arrangement of aheadband assembly and the frame including a pair of lower couplingstructures structured to be removably connectable to a lower bandarrangement of the headband assembly for maintaining the maskarrangement in a desired position on a patient's face; the foreheadpadding of the forehead support being integrally formed in one piecealong with a cheek engaging portion.
 35. The breathing mask arrangementaccording to claim 34, wherein the forehead support is T-shaped.
 36. Thebreathing mask arrangement according to claim 34, wherein the foreheadpadding of the forehead support and the cheek engaging portion are madeof an elastomer material.
 37. The breathing mask arrangement accordingto claim 34, wherein the mask is a nasal mask.
 38. The breathing maskarrangement according to claim 4, wherein the frame is constructed of amaterial different than the elastomeric material of the mask.
 39. Thebreathing mask arrangement according to claim 4, wherein gas dischargeopenings are provided on the elastomeric material.
 40. The breathingmask arrangement according to claim 4, wherein the mask interiorbreathing chamber is formed substantially by the elastomeric material ofthe body portion and the sealing portion.
 41. The breathing maskarrangement according to claim 4, wherein the body portion passesthrough the mask retaining portion.
 42. The breathing mask arrangementaccording to claim 4, wherein the frame includes a pair of uppercoupling structures structured to be removably connectable to an upperband arrangement of a headband assembly and a pair of lower couplingstructures structured to be removably connectable to a lower bandarrangement of the headband assembly for maintaining the maskarrangement in a desired position on a patients face.